Breast CancerPROBINCT02941835
Preoperative Breast Irradiation
A study testing pre-operative irradiation in people with Breast Cancer, run by The Netherlands Cancer Institute at 1 site in Netherlands.
Trial summary
The PROBI is a phase I/II trial assessing the feasibility of preoperative whole breast irradiation in female patients with low to intermediate risk breast cancer, who undergo breast conserving therapy, including a boost dose of irradiation. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- pre-operative irradiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteNetherlands
- Study dates
- 12 Mar 2018to 9 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Histologically proven invasive breast carcinoma
- cT1-2N0 breast cancer
- cM0
- female patients ≤ 50 years
- planned breast conserving surgery
- ability to undergo irradiation and surgery
- signed written informed consent
Who cannot join
- prior surgery or radiotherapy for the protocol tumor (neoadjuvant chemotherapy or endocrine therapy is allowed)
- planned oncoplastic reduction mammoplasty
- cTis
- extensive calcifications on mammagram (Birads 3,4 or 5)
- cT3-4 and/or cN1-3 invasive carcinoma
- distant metastasis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preoperative Breast Irradiation, the PROBI Trial. A Phase I/II Feasibility Trial
The PROBI is a phase I/II trial assessing the feasibility of preoperative whole breast irradiation in female patients with low to intermediate risk breast cancer, who undergo breast conserving therapy, including a boost dose of irradiation.
An additional goal of this study is to assess tumor response to radiotherapy, by imaging modalities (PET-CT and MRI) and pathology
- Conditions
- Breast Cancer
- Being tested
- pre-operative irradiation
- Keywords
- pre-operative radiotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pre-operative irradiationRadiation
Also called radiotherapy
pre-operative whole breast irradiation of 21 fx of 2.2Gy and boost of 2.66Gy
| Study group | Role | What they receive |
|---|---|---|
| radiation | Other | intervention: pre-operative breast irradiation of 21 fx of 2.2Gy and boost 2.66Gy Receives: Radiation: pre-operative irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative surgical complications
postoperative complication will be scored by a specific list
Measured: within six weeks after surgery
Secondary outcomes (3)
Radiological response
assessed by MRI
Measured: 6 weeks post-radiation
Pathological response
surgery specimen
Measured: at surgery
cosmetic outcome
cosmesis will be scored by physician by questionnaire and cosmesis will be cored by patient by questionnaire
Measured: 1,3 and 5 years post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2016 (estimated)
- Study start12 Mar 2018
- Primary completion9 Aug 2018
- Study completion9 Aug 2018
Why it stopped: slow inclusion rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Astrid Scholten, MD, PhD, Principal investigator, Antoni van Leeuwenhoek
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02941835
- Sponsor's protocol ID
- N16PRB
- Other IDs
- NL59561.031.16
- Acronym
- PROBI
- Status last verified
- Oct 2019
- First submitted
- 20 Oct 2016
- Last updated
- 22 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bartelink H, Maingon P, Poortmans P, Weltens C, Fourquet A, Jager J, Schinagl D, Oei B, Rodenhuis C, Horiot JC, Struikmans H, Van Limbergen E, Kirova Y, Elkhuizen P, Bongartz R, Miralbell R, Morgan D, Dubois JB, Remouchamps V, Mirimanoff RO, Collette S, Collette L; European Organisation for Research and Treatment of Cancer Radiation Oncology and Breast Cancer Groups. Whole-breast irradiation with or without a boost for patients treated with breast-conserving surgery for early breast cancer: 20-year follow-up of a randomised phase 3 trial. Lancet Oncol. 2015 Jan;16(1):47-56. doi: 10.1016/S1470-2045(14)71156-8. Epub 2014 Dec 9.
PubMed 25500422Donker M, Straver ME, Wesseling J, Loo CE, Schot M, Drukker CA, van Tinteren H, Sonke GS, Rutgers EJ, Vrancken Peeters MJ. Marking axillary lymph nodes with radioactive iodine seeds for axillary staging after neoadjuvant systemic treatment in breast cancer patients: the MARI procedure. Ann Surg. 2015 Feb;261(2):378-82. doi: 10.1097/SLA.0000000000000558.
PubMed 24743607Egro FM, Pinell-White X, Hart AM, Losken A. The use of reduction mammaplasty with breast conservation therapy: an analysis of timing and outcomes. Plast Reconstr Surg. 2015 Jun;135(6):963e-971e. doi: 10.1097/PRS.0000000000001274.
PubMed 26017612Jones HA, Antonini N, Hart AA, Peterse JL, Horiot JC, Collin F, Poortmans PM, Oei SB, Collette L, Struikmans H, Van den Bogaert WF, Fourquet A, Jager JJ, Schinagl DA, Warlam-Rodenhuis CC, Bartelink H. Impact of pathological characteristics on local relapse after breast-conserving therapy: a subgroup analysis of the EORTC boost versus no boost trial. J Clin Oncol. 2009 Oct 20;27(30):4939-47. doi: 10.1200/JCO.2008.21.5764. Epub 2009 Aug 31.
PubMed 19720914van de Vijver MJ, He YD, van't Veer LJ, Dai H, Hart AA, Voskuil DW, Schreiber GJ, Peterse JL, Roberts C, Marton MJ, Parrish M, Atsma D, Witteveen A, Glas A, Delahaye L, van der Velde T, Bartelink H, Rodenhuis S, Rutgers ET, Friend SH, Bernards R. A gene-expression signature as a predictor of survival in breast cancer. N Engl J Med. 2002 Dec 19;347(25):1999-2009. doi: 10.1056/NEJMoa021967.
PubMed 12490681
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Breast Irradiation, the PROBI Trial. A Phase I/II Feasibility Trial
- ClinicalTrials.gov ID
- NCT02941835
- Acronym / sponsor ID
- PROBI / N16PRB
- Conditions
- Breast Cancer
- Keywords
- pre-operative radiotherapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow inclusion rate
- Enrolment
- 4 participants (actual)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Study start
- 12 Mar 2018 (actual)
- Primary completion
- 9 Aug 2018 (actual)
- Study completion
- 9 Aug 2018 (actual)
- First posted
- 21 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The PROBI is a phase I/II trial assessing the feasibility of preoperative whole breast irradiation in female patients with low to intermediate risk breast cancer, who undergo breast conserving therapy, including a boost dose of irradiation.
An additional goal of this study is to assess tumor response to radiotherapy, by imaging modalities (PET-CT and MRI) and pathology
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| radiation | Other | Radiation: pre-operative irradiationintervention: pre-operative breast irradiation of 21 fx of 2.2Gy and boost 2.66Gy |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Histologically proven invasive breast carcinoma
- cT1-2N0 breast cancer
- cM0
- female patients ≤ 50 years
- planned breast conserving surgery
Key exclusion criteria (6 listed)
- prior surgery or radiotherapy for the protocol tumor (neoadjuvant chemotherapy or endocrine therapy is allowed)
- planned oncoplastic reduction mammoplasty
- cTis
- extensive calcifications on mammagram (Birads 3,4 or 5)
- cT3-4 and/or cN1-3 invasive carcinoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pre-operative irradiationAlso: radiotherapypre-operative whole breast irradiation of 21 fx of 2.2Gy and boost of 2.66Gy | Radiation | radiation |
Primary outcome
Postoperative surgical complications
Time frame: within six weeks after surgery
postoperative complication will be scored by a specific list
3 secondary outcomes
Radiological response
Time frame: 6 weeks post-radiation
Pathological response
Time frame: at surgery
cosmetic outcome
Time frame: 1,3 and 5 years post-treatment
Results and safety
The study was stopped early (reason given: slow inclusion rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2019.
- Background: PubMed 25500422Bartelink H, Maingon P, Poortmans P, Weltens C, Fourquet A, Jager J, Schinagl D, Oei B, Rodenhuis C, Horiot JC, Struikmans H, Van Limbergen E, Kirova Y, Elkhuizen P, Bongartz R, Miralbell R, Morgan D, Dubois JB, Remouchamps V, Mirimanoff RO, Collette S, Collette L; European Organisation for Research and Treatment of Cancer Radiation Oncology and Breast Cancer Groups. Whole-breast irradiation with or without a boost for patients treated with breast-conserving surgery for early breast cancer: 20-year follow-up of a randomised phase 3 trial. Lancet Oncol. 2015 Jan;16(1):47-56. doi: 10.1016/S1470-2045(14)71156-8. Epub 2014 Dec 9.
- Background: PubMed 24743607Donker M, Straver ME, Wesseling J, Loo CE, Schot M, Drukker CA, van Tinteren H, Sonke GS, Rutgers EJ, Vrancken Peeters MJ. Marking axillary lymph nodes with radioactive iodine seeds for axillary staging after neoadjuvant systemic treatment in breast cancer patients: the MARI procedure. Ann Surg. 2015 Feb;261(2):378-82. doi: 10.1097/SLA.0000000000000558.
- Background: PubMed 26017612Egro FM, Pinell-White X, Hart AM, Losken A. The use of reduction mammaplasty with breast conservation therapy: an analysis of timing and outcomes. Plast Reconstr Surg. 2015 Jun;135(6):963e-971e. doi: 10.1097/PRS.0000000000001274.
- Background: PubMed 19720914Jones HA, Antonini N, Hart AA, Peterse JL, Horiot JC, Collin F, Poortmans PM, Oei SB, Collette L, Struikmans H, Van den Bogaert WF, Fourquet A, Jager JJ, Schinagl DA, Warlam-Rodenhuis CC, Bartelink H. Impact of pathological characteristics on local relapse after breast-conserving therapy: a subgroup analysis of the EORTC boost versus no boost trial. J Clin Oncol. 2009 Oct 20;27(30):4939-47. doi: 10.1200/JCO.2008.21.5764. Epub 2009 Aug 31.
- Background: PubMed 12490681van de Vijver MJ, He YD, van't Veer LJ, Dai H, Hart AA, Voskuil DW, Schreiber GJ, Peterse JL, Roberts C, Marton MJ, Parrish M, Atsma D, Witteveen A, Glas A, Delahaye L, van der Velde T, Bartelink H, Rodenhuis S, Rutgers ET, Friend SH, Bernards R. A gene-expression signature as a predictor of survival in breast cancer. N Engl J Med. 2002 Dec 19;347(25):1999-2009. doi: 10.1056/NEJMoa021967.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Astrid Scholten, MD, PhD principal investigator
Antoni van Leeuwenhoek
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pre-operative irradiation in people with Breast Cancer, run by The Netherlands Cancer Institute at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: slow inclusion rate). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative surgical complications (time frame: within six weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02941835, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2019.